NCT00461929

Brief Summary

In order to distinguish between clonal instability driven by imatinib in CML and actual changes with secondary clones induced by imatinib we would like to investigate the karyotype of non-CML patients treated with imatinib such as GIST patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 13, 2009

Status Verified

April 1, 2007

Enrollment Period

3.8 years

First QC Date

April 16, 2007

Last Update Submit

February 12, 2009

Conditions

Chronic Myeloid LeukemiaGastrointestinal Stromal Cell TumorsChromosome Abnormality

Keywords

chronic myeloid leukemiagastrointestinal stromal cell tumorschromosome abnormalityimatinibbone marrow aspiration

Outcome Measures

Primary Outcomes (1)

  • ~ presence or absence of genetic abnormality as seen in CML patients on imatinib

Interventions

bone marrow aspirationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • GIST patient on Imatinib for more than 12 months

You may not qualify if:

  • nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveChromosome Aberrations

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeff Lipton, MD

    University Health Network, DMOH

    PRINCIPAL INVESTIGATOR

  • Martin Blackstein, MD

    MOUNT SINAI HOSPITAL

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2007

First Posted

April 18, 2007

Study Start

February 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 13, 2009

Record last verified: 2007-04

Locations

CA(2)